[Clinical study of serum N-terminal propeptide of type Ⅲ collagen combined with platelet count for the diagnosis of chronic hepatitis B-related liver fibrosis].

Abstract

Objective: The development of advanced liver fibrosis in patients with chronic hepatitis B (CHB) significantly increases the risk of cirrhosis and liver cancer; therefore, early diagnosis is crucial for improving prognosis. Accordingly, this study established a diagnostic model combining serum N-terminal pro-peptide of type Ⅲ collagen (PRO-C3) and platelet count (PLT) to enhance the diagnostic performance for advanced liver fibrosis in CHB patients. Methods: This study included CHB patients who had not received prior treatment and underwent liver biopsy at the Drum Tower Hospital affiliated with the Medical School of Nanjing University and Suzhou Fifth People's Hospital between October 15, 2017, and December 30 2021. Logistic regression analysis was used to identify risk factors for advanced liver fibrosis in patients with CHB and to establish a non-invasive model. The model's performance was evaluated using receiver operating characteristic (ROC) curves and decision curve analysis, while the DeLong test was employed to assess whether differences in the areas under the receiver operating characteristic curves (AUCs) among the non-invasive scores were statistically significant. Results: Data from a total of 324 patients were included in the study, of whom 83 patients (25.6%) had advanced liver fibrosis. Multivariate logistic regression analysis revealed that PRO-C3 (odds ratio=1.04, P<0.01) and PLT (odds ratio=0.99, P=0.04) were independent occurrence risk factors for advanced liver fibrosis in patients with CHB. The diagnostic model for advanced liver fibrosis based on PRO-C3 combined with PLT had an area under the receiver operating characteristic curve (AUC) of 0.80 (95% confidence interval [CI], 0.74-0.85) in the training cohort, which was significantly higher than that of the Fibrosis-4 index (FIB-4) (AUC, 0.67; 95%CI, 0.60-0.73; P<0.01) and the aspartate aminotransferase-to-platelet ratio index (APRI) (AUC, 0.71; 95%CI, 0.65-0.77; P=0.02). The differences in AUCs between the diagnostic model and the aforementioned non-invasive scores were statistically significant. Furthermore, the combined model demonstrated stable diagnostic performance across various clinical subgroups, including gender, age, alanine aminotransferase levels, HBeAg status, and HBV DNA levels (AUC: 0.73-0.84). The combined model and the aforementioned subgroups achieved favorable diagnostic performance in the validation cohort for advanced liver fibrosis in patients with CHB, with an AUC of 0.84 (95%CI, 0.75-0.91) and (AUC: 0.78-0.94), respectively. Conclusion: The non-invasive diagnostic model established by combining serum PRO-C3 and PLT shows favorable diagnostic value for CHB-related advanced liver fibrosis, and its performance is superior to commonly used non-invasive scores such as the Fibrosis-4 index and the aspartate aminotransferase-to-platelet ratio index. This simple and reliable model may provide a new clinical tool for the non-invasive diagnosis of CHB-related liver fibrosis.